XILIARX 50 mg Film-Coated Tablets

Зміст інструкції

1. Xiliarx 50 mg tablets
   1. What is Xiliarx and what is it used for
   2. What you need to know before you take Xiliarx
   3. How to take Xiliarx
   4. Possible side effects
   5. How to store Xiliarx
   6. Package contents and other information

Xiliarx 50 mg tablets

vildagliptin

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

• 1. What Xiliarx is and what it is used for
• 2. What you need to know before you take Xiliarx
• 3. How to take Xiliarx
• 4. Possible side effects
• 5. How to store Xiliarx
• 6. Contents of the pack and other information

1. What is Xiliarx and what is it used for

The active substance of Xiliarx, vildagliptin, belongs to a group of medicines called
“oral antidiabetics”.
Xiliarx is used to treat adult patients with type 2 diabetes. It is used when diabetes cannot be
controlled by diet and exercise alone. It helps to control blood sugar levels. Your doctor will prescribe
Xiliarx alone or together with other antidiabetic medicines that you are already taking, if these have
not proven sufficiently effective in controlling diabetes.
Type 2 diabetes develops when the body does not produce enough insulin, or if the insulin
produced by the body does not work as it should. It can also develop when the body
produces too much glucagon.
Insulin is a substance that helps lower blood sugar levels, especially after
meals. Glucagon is a substance that triggers the production of sugar by the liver,
causing an increase in blood sugar levels. The pancreas produces both of these
substances.

How Xiliarx works
Xiliarx works by inducing the pancreas to produce more insulin and less glucagon. This helps to control
blood sugar levels. This medicine has been shown to reduce blood sugar.
This can help prevent complications arising from your diabetes. Even if you are now starting to
take medicine for diabetes, it is important that you continue to follow the diet and/or exercise
that has been recommended to you.

2. What you need to know before you take Xiliarx

Do not take Xiliarx:

• if you are allergic to vildagliptin or to any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic to vildagliptin or any of the excipients of Xiliarx, do not take this medicine and consult your doctor.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Xiliarx

• if you have type 1 diabetes (i.e. your body does not produce insulin) or if you suffer from a condition called diabetic ketoacidosis.
• if you are taking a medicine for diabetes known as a sulfonylurea (if you take it together with Xiliarx, your doctor may want to reduce your dose of sulfonylurea, to avoid low blood glucose levels [hypoglycemia]).
• if you have moderate or severe kidney disease (you will need to take a lower dose of Xiliarx).
• if you are on dialysis
• if you have liver disease
• if you suffer from heart failure
• if you have or have had a disease of the pancreas

If you have previously taken vildagliptin but had to stop due to liver disease, you should not
take this medicine.
Skin lesions are a common complication of diabetes. It is advisable to follow the
recommendations for skin and foot care that are provided to you by your doctor or nurse.
It is also advisable to pay particular attention to the appearance of blisters or ulcers while
taking Xiliarx. If this occurs, you should quickly consult your doctor.
Before starting treatment with Xiliarx, a test will be performed to assess liver function, which will be repeated every three months during the first year of treatment and subsequently
periodically. This is to detect as early as possible signs of increased liver enzymes.

Children and adolescents
The use of Xiliarx is not recommended in children and adolescents under 18 years of age.

Other medicines and Xiliarx
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Your doctor may want to adjust the dose of Xiliarx if you are taking other medicines such as
for example:

• thiazides or other diuretics (also called water tablets)
• corticosteroids (generally used for the treatment of inflammation)
• thyroid medicines
• certain medicines that act on the nervous system.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.
You should not use Xiliarx during pregnancy. It is not known whether Xiliarx passes into breast milk. You should not
use Xiliarx if you are breastfeeding or planning to breastfeed.

Driving and using machines
If you feel dizzy when taking Xiliarx, do not drive or use machines.

Xiliarx contains lactose
Xiliarx contains lactose (milk sugar). If your doctor has diagnosed you with intolerance to
certain sugars, contact him before taking this medicine.

Xiliarxcontains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, therefore it is essentially
‘sodium-free’.

3. How to take Xiliarx

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor or pharmacist.

How much to take and when
The amount of Xiliarx that must be taken varies depending on individual conditions. Your doctor will
tell you exactly how many Xiliarx tablets you must take. The maximum daily dose is 100 mg.
The usual dose of Xiliarx is:

• 50 mg per day taken as a single dose in the morning if you take Xiliarx with another medicine called a sulfonylurea.
• 100 mg per day taken as 50 mg in the morning and 50 mg in the evening if you take Xiliarx alone, with another medicine called metformin or a glitazone, with a combination of metformin and a sulfonylurea, or with insulin.
• 50 mg per day in the morning if you have a moderate or severe degree of kidney disease or if you are on dialysis.

How to take Xiliarx

• Take the tablets with a little water.

For how long to take Xiliarx

• Take Xiliarx every day until your doctor advises you to do so. It is possible that you may need to continue this treatment for a long period of time.
• Your doctor will regularly check your condition to verify that the treatment is having the desired effect.

If you take more Xiliarx than you should
If you take too many Xiliarx tablets, or if someone else has taken your medicine, contact your
doctor immediately. Medical care may be necessary. If you need to see a
doctor or go to the hospital, take the packaging with you.

If you forget to take Xiliarx
If you forget to take a dose of this medicine, take it as soon as you remember. Then take your
next dose at the usual time. If it is almost time for your next dose, skip the dose you forgot. Do not take a double dose to make up for a missed tablet.

If you stop taking Xiliarx
Do not stop taking Xiliarx unless your doctor tells you to do so. If you have doubts about the duration of
treatment with this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some symptoms require immediate medical attention:
You must stop taking Xiliarx and contact your doctor immediately if you experience any of the
following side effects:

• Angioedema (rare: may affect up to 1 in 1,000 people): Symptoms include swelling of the face, tongue or throat, difficulty swallowing, difficulty breathing, sudden onset of skin rashes or hives, which may indicate a reaction called “angioedema”.
• Liver disease (hepatitis) (frequency not known): Symptoms include yellowing of the skin and eyes, nausea, loss of appetite or dark urine, which may indicate liver disease (hepatitis).
• Inflammation of the pancreas (pancreatitis) (rare: may affect up to 1 in 1,000 people). Symptoms include severe and persistent abdominal pain (stomach area), which may spread to the back, as well as nausea and vomiting.

Other side effects
While taking Xiliarx, some patients have experienced the following side effects:

• Very common (may affect more than 1 in 10 people): sore throat, runny nose, fever
• Common: (may affect up to 1 in 10 people): itchy skin rash, tremor, headache, dizziness, muscle pain, joint pain, constipation, swelling of hands, ankles or feet (edema), excessive sweating, vomiting, pain in the stomach and around the stomach (abdominal pain), diarrhea, heartburn, nausea (feeling sick), blurred vision.
• Uncommon: may affect up to 1 in 100 people): weight gain, chills, weakness, sexual dysfunction, low blood glucose levels, flatulence.
• Rare (may affect up to 1 in 1,000 people): inflammation of the pancreas

The following side effects have also been reported during the marketing of this medicine:

• Frequency not known (cannot be estimated from the available data): localized skin peeling or blisters, inflammation of blood vessels (vasculitis), which may cause skin rash or flat, round, red spots, raised under the skin surface or bruising.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system listed in Annex V. By reporting side effects you can help
provide more information on the safety of this medicine.

5. How to store Xiliarx

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date that is stated on the blister and the carton after “EXP”/ “Scad.”. The expiry date refers to the last day of that month.
• Store in the original package to protect the medicine from moisture.
• Do not use a package of Xiliarx that is damaged or shows signs of tampering.
• Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment

6. Package contents and other information

What Xiliarx contains

• The active ingredient is vildagliptin. Each tablet contains 50 mg of vildagliptin.
• The other ingredients are anhydrous lactose, microcrystalline cellulose, sodium starch glycolate (type A) and magnesium stearate.

Description of the appearance of Xiliarx and contents of the pack
Xiliarx 50 mg tablets are round, flat, from white to slightly yellowish, with imprinted
“NVR” on one side and “FB” on the other.
Xiliarx 50 mg tablets are available in packs containing 7, 14, 28, 30, 56, 60, 90, 112,
180 or 336 tablets and in multiple packs containing 3 boxes, each containing 112 tablets.
Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland

Manufacturer
Lek d.d.
Verovskova ulica 57
Ljubljana 1526
Slovenia
Novartis Farmacéutica S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain
Novartis Pharma GmbH
Roonstrasse 25
D-90429 Nuremberg
Germany
Novartis Pharmaceutical Manufacturing LLC
Verovskova ulica 57
Ljubljana 1000
Slovenia
For further information on this medicinal product, contact the local representative of the
Marketing Authorisation Holder:

België/Belgique/Belgien
Novartis Pharma N.V.
Tél/Tel: +32 2 246 16 11

Lietuva
SIA Novartis Baltics Lietuvos filialas
Tel: +370 5 269 16 50

България
Novartis Bulgaria EOOD
Тел.: +359 2 489 98 28

Luxembourg/Luxemburg
Novartis Pharma N.V.
Tél/Tel: +32 2 246 16 11

Česká republika
Novartis s.r.o.
Tel: +420 225 775 111

Magyarország
Novartis Hungária Kft.
Tel.: +36 1 457 65 00

Danmark
Novartis Healthcare A/S
Tlf: +45 39 16 84 00

Malta
Novartis Pharma Services Inc.
Tel: +356 2122 2872

Deutschland
Novartis Pharma GmbH
Tel: +49 911 273 0

Nederland
Novartis Pharma B.V.
Tel: +31 88 04 52 111

Eesti
SIA Novartis Baltics Eesti filiaal
Tel: +372 66 30 810

Norge
Novartis Norge AS
Tlf: +47 23 05 20 00

Ελλάδα
Novartis (Hellas) A.E.B.E.
Τηλ: +30 210 281 17 12

Österreich
Novartis Pharma GmbH
Tel: +43 1 86 6570

España
Laboratorios Gebro Pharma, S.A.
Tel: +34 93 205 86 86

Polska
Novartis Poland Sp. z o.o.
Tel.: +48 22 375 4888

France
Novartis Pharma S.A.S.
Tél: +33 1 55 47 66 00

Portugal
Laboratório Normal – Produtos Farmacêuticos
Lda.
Tel. +351 21 000 8600

Hrvatska
Novartis Hrvatska d.o.o.
Tel. +385 1 6274 220

România
Novartis Pharma Services Romania SRL
Tel: +40 21 31299 01

Ireland
Novartis Ireland Limited
Tel: +353 1 260 12 55

Slovenija
Novartis Pharma Services Inc.
Tel: +386 1 300 75 50

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
Novartis Slovakia s.r.o.
Tel: +421 2 5542 5439

Italia
Novartis Farma S.p.A.
Tel: +39 02 96 54 1

Suomi/Finland
Novartis Finland Oy
Puh/Tel: +358 (0)10 6133 200

Κύπρος
Novartis Pharma Services Inc.
Τηλ: +357 22 690 690

Sverige
Novartis Sverige AB
Tel: +46 8 732 32 00

Latvija
SIA Novartis Baltics
Tel: +371 67 887 070

United Kingdom (Northern Ireland)
Novartis Ireland Limited
Tel: +44 1276 698370

Other sources of information
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu